What's new at CDER by Date New and Generic Drug Approvals Curosurf (poractant alfa) Intratracheal Suspension, Dey Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals HYDREA (hydroxyurea) Capsules, Bristol-Myers Squibb Company Methergine (Methylergonovine Maleate) Tablets & Injection, Novartis M.V.IHydrochloride Tablets, Mylan...
author: Paul Stauffer
http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD ...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
Prescription and OTC Drug Product List 6/2002 45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
TIMPILO Product Monograph PRODUCT MONOGRAPH TIMPILO ® (timolol maleate and pilocarpine hydrochloride ophthalmic solution) Sterile Olphthalmic Solution THERAPEUTIC CLASSIFICATION ELEVATED INTRAOCULAR PRESSURE THERAPY DESCRIPTION TIMPILO ® (timolol maleate and pilocarpine hydrochloride) is a fixed combination of timolol maleate 0.5% and pilocarpine hydrochloride 2% (TIMPILO ® 2) or 4% (TIMPILO &...
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
TIMPILO Product Monograph page 5
author: Merck Frosst Canada & Co.
subject: 644-a,5,00
COSOPT - Product Monograph Additional adverse reactions that have been seen with one of the components and may be potential adverse reactions of COSOPT ® are: Dorzolamide Hydrochloride Headache; eyelid inflammation; eyelid crusting; nausea; eyelid irritation; asthenia/ fatigue; iridocyclitis; rash; dizziness; paraesthesia; superficial punctate keratitis, transient myopia (which resolved upon...
author: Merck Frosst Canada Ltd.
subject: 778-b,11,02
Hampton Research - Tips from A to Z --Products------ Customer Service------ Technical Support------ Cool Stuff------ About Us------ Search------ - Technical Support -- Tips from A to Z - Tips from A to Z Search for an A to Z tip using a keyword or simply browse below
author: Hampton Research Corp.
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
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Prescription and OTC Drug Product List 6/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 6: June 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL OXYCODONE AND ACETAMINOPHEN CAPOZIDE 25/15 - ADD - AA DURAMED 325MG;5MG N40272 001 - ADD - AB...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX...
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
FDA Drug Approvals List- August 1998 Drug Approvals for September 1998 Definitions and Notes September 1998 Original New Drug Applications Original Application #: 050744 Approval Date: 30-SEP-98 Trade Name: PERIOSTAT Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: COLLAGENEX INC Active Ingredient(s): DOXYCYCLINE HYCLATE OTC/RX Status: RX Indication(s): To promote attachment level gain and to...
DDPA December 1995 74-589 MINOXIDIL LEMMON MINOXIDIL 15-DEC-95 (SOLUTION) SELLERSVILLE, PA 2% 18960 (HAIR GROWTH STIMULATOR) 74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL 22-DEC-95 (SOLUTION) TAMPA, FL 2% 33637 (HAIR GROWTH STIMULATOR) 74-418 CAPTOPRIL ENDO CAPTOPRIL 28-DEC-95 (TABLET) GARDEN CITY, NY 12.5MG 11530 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO...
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
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